Research Report Of Clinical Studies Ⅱ Of Malignant Glioma Treated By Iodine(～(131)Ⅰ) Tumor Necrosis Therapy Monoclonal Antibody Injection

Neurogliocytoma is a kind of frequent malignant intracranial tumor, because most of the tumors displays infiltrative growth, have obscure boundary with the surrounding brain tissue, and such tumors often involve in important functional domain, it's therefore difficult for the operation to perform tumor total resection. Even if the majority of people were treated with surgical operation and post operational combined therapy, recurrence is frequent and recovery is unsatisfied. With the increasingly profound study in molecular pathology of neurogliocytoma and the development of correlated subjects, such as immunology and gene engineering, the human kind are fighting for exploring new treatment, among of which, radioimmunotherapy have been a hot spot to cure neurogliocytoma.This study adopted random and open second stage clinical trial to compare the curative effect and safe between the ¹³¹â… -chTNT injection an BCNU used in treatment of malignant neurogliocytoma., and to investigate the availability and safe of single course of treatment local injection of ¹³¹â… -chTNT. Methods, results and conclusions are as follows:Materials and methods: This research objects sourced from the department of neurosurgery of Nanfang hospital, these patients suffered with recurred neurogliocytoma were in hospital from May, 2005 to October, 2006. Patients are filtered according to the select standard and remove standard, numbered randomly and arranged into control group and test group, 14 cases in the former group and 12 in the latter group. Pathological diagnosis is: 20 cases with 3-4 degree astrocytoma, 4 cases with 3-4 degree mesoglioma, 2 cases with glioblastoma multiforme. Control group and test group are treated with BCNU and¹³¹I—chTNT respectively. Follow-up period is over 6 months. Observe index include the tumors image change and KPS scores before therapy, three months after therapy and six months after therapy; SPECT scan images show the body distribution of test group; hemogram index including WBC,RBC,HGB,PLT; function of thyroid including TSH,T3,T4,FrT3,FrT4; liver and renal function including AST,ALT,CR,BUN.Results: There were no evident differences between the two groups in gross tumor volume whether pretherapy or posttherapy, KPS score and life span. MR images suggest that: the total effectve power of the test group is 66.67ï¼…, and the control group is 35.71ï¼…, but this result indicated there is no significant difference between the two groups (P＞0.05). SPECT scan images showed that injecting ¹³¹I-chTNT through the OMAYA made of silica gel cyst could enhance the radioactive drug's concentration in the tumor cavity and increase the chance for ¹³¹I-chTNT to contact with remnant tumor directly, therefore strengthen the biological availability of ¹³¹I-chTNT. Radiational encephaledema was observed in test group from the MR and CT images.Numbers of leucocyte, akaryocyte, hemoglobin, and platelet changed before and after the therapy, but fluctuated in the range of normal values. The two group had no significant differences (P＞0.05) in TSH,T3,T4,FrT3,FrT4 before and after the therapy, whereas besides FrT3 The two group had significant differences(P＜0.001) three months before therapy, three months after therapy and six months after therapy, this indicated that thyroid function fluctuate during the period of therapy.The two group had significant difference (P＜0.05) in the level of AST, but no significant difference (P＞0.05) in the level of ALT. The level of AST and ALT fluctuated in the range of normal values three months before therapy, three months after therapy and six months after therapy. But severe liver functional lesion was not observed. The two group had no significant difference (P＞0.05) in the level of CR and BUN, and their level fluctuated in the range of normal values three months before therapy, three months after therapy and six months after therapy. Conclusions: After monoclonal antibody conjugated with ¹³¹I-chTNT, the combined agent can d target nucleus of the tumor cells,then the radioiodine is transported intotumor cells and destroyed the cell. Intratumoral radiotherapy by ¹³¹I chTNT performs efficiently, and demonstrates a significant virtue compared with other interstitial brachytherapies for malignant brain tumors.1.¹³¹I-chTNT is effective to cure the neurogliocytoma, and its effective power is probably higher than BCNU.2. Injecting the ¹³¹I-chTNT through local OMAYA cyst is safe and reliable.3. Curative dose of ¹³¹I-chTNT could induce wide-ranging radiate encephaledema.4. Curative dose of ¹³¹I-chTNT have no evident effect on myelosuppression.5. Curative dose of ¹³¹I-chTNT have certain effect on thyroid function.6. Curative dose of ¹³¹I-chTNT affect the liver and renal function slightly. Overall the ¹³¹I-chTNT is neotype radioimmunological preparation for the therapy of neurogliocytoma, and it's clinically safe and effective.